IV Antibiotics With Lavage for Severe PD Peritonitis

Alice Ho Miu Ling Nethersole Hospital

Status and phase: Completed; Phase 4

Conditions: Kidney Failure; Peritonitis

Treatments: Drug: Intravenous vancomycin & gentamicin with adjunctive lavage; Drug: Intraperitoneal vancomycin & gentamicin

Study type: Interventional

Funder types: Other

Identifiers

NCT02926846

2013.201

Details and patient eligibility

About

This is a randomized controlled trial to evaluate whether a switch to intravenous antibiotics with adjunctive lavage can improve the outcome of severe peritoneal dialysis related peritonitis.

Full description

The standard treatment of peritoneal dialysis (PD) related peritonitis is intraperitoneal (IP) antibiotics. In severe cases not responding to the IP antibiotics treatment, timely Tenckhoff catheter removal is needed. There is no known adjunctive measure that can improve the clinical outcome of the patients suffering from severe PD peritonitis.

Based on the past experience in the investigators' center, switching IP to intravenous route of antibiotics administration, together with adjunctive lavage was proposed to improve the clinical outcome of severe PD peritonitis, in particular a possible improved catheter salvage rate. This method will be evaluated in the present clinical trial.

Enrollment: 46 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Prevalent PD patients with age >= 18 years old suffering from PD peritonitis
• PD effluent white cell count >1090/mm2 on peritonitis day 3
• Lack of clinical response
• Informed consent available

Exclusion criteria

• PD peritonitis in association with exit site or tunnel infection
• Relapsing peritonitis (i.e. peritonitis caused by same organism within 4 weeks after completion of antibiotics therapy)
• Fungal peritonitis
• Mycobacterial peritonitis (both tuberculosis and non-tuberculosis species)
• Clinical suspicion of surgical peritonitis
• Penicillin- or cephalosporin allergy, that cefazolin and ceftazidime could not be used

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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46 participants in 2 patient groups

Lavage arm

Experimental group

Description:

Intravenous vancomycin \& gentamicin with adjunctive lavage

Treatment:

Drug: Intravenous vancomycin & gentamicin with adjunctive lavage

Standard treatment arm

Active Comparator group

Description:

Intraperitoneal vancomycin \& gentamicin

Treatment:

Drug: Intraperitoneal vancomycin & gentamicin